(AstraZeneca) May 7, 2021 - POSEIDON was a Phase III trial of AstraZeneca’s Imfinzi (durvalumab) plus platinum-based chemotherapy or Imfinzi, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). Positive high-level results from the final analysis of POSEIDON showed the combination of Imfinzi, tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone.

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H. Jack West, MD (Posted: May 07, 2021)

The oncologic embodiment of a Pyrrhic victory. With these data, the combination of durvalumab with tremelimumab has the opportunity to become an inconsequential additional alternative that provides no advantage over many better established options in this setting that are destined to be higher choices. We even already have another PD-1/CTLA-4 inhibitor combination with nivolumab/ipilimumab that has a proven OS benefit over chemo alone in this setting, and which is already FDA approved (for patients with PD-L1 1% or higher) but has almost no use because it offered no clear incremental benefit over the far preferred option of chemo/pembrolizumab for a broad population of patients in the first-line setting. It will be interesting to see what AZ does with this, because I don't think marketing efforts will be covered by the 0.2% of the market it will capture.

(Roche) May 5, 2021 - Roche today announced that the European Commission has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression*, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. “We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease.”

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H. Jack West, MD (Posted: May 05, 2021)

A fine alternative to pembrolizumab, which is the current standard of care in this setting after establishing a clear and sustained survival benefit over chemotherapy in the KEYNOTE-024 trial, but a lateral move that offers no incremental benefit over what we already have with pembrolizumab in this setting.

(BioSpace) Apr 28, 2021 - Takeda’s non-small cell lung cancer (NSCLC) treatment Mobocertinib (TAK-788) is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date for Oct. 26.

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H. Jack West, MD (Posted: May 01, 2021)

Mobocertinib doesn't offer activity at a level of osimertinib for EGFR mutated NSCLC or alectinib for ALK-positive NSCLC, and it presents some challenges in terms of tolerability, but it fulfills a real unmet need for this patient population. I know I and my patients with advanced NSCLC harboring an EGFR exon 20 insertion mutation would welcome having it approved and commercially available.